S1065 Endoscopic and Histologic Remission After 2 Years Treatment With Mirikizumab in Patients With Moderately-to-Severely Active Ulcerative Colitis
Bibliographic record
Abstract
Introduction: Mirikizumab (miri), a p19-directed IL-23 antibody, has shown efficacy in achieving clinical, endoscopic and histological response and remission after 52 weeks of therapy in patients with moderately-to-severely active ulcerative colitis (UC) in Phase 3 trials (LUCENT-1,; LUCENT-2). Histological healing in UC can indicate remission depth. Here, we report from LUCENT-3 the proportion of patients with and without prior biologic or tofacitinib failure who achieved histologic and endoscopic remission after 2 years of miri treatment. Methods: LUCENT-3 is an ongoing, single-arm, outpatient, multicenter, long-term extension Phase 3 study evaluating the efficacy and safety of miri in patients with moderately-to-severely active UC. All enrolled patients received open-label subcutaneous miri 200 mg every 4 weeks. This analysis focused on miri responders at Week (W)52 (patients who were responders at W12, were re-randomized to miri maintenance and were in response at the end of LUCENT-2) who were enrolled in the long-term extension and continued to receive miri for additional 52 weeks. Endpoints of interest are the proportions of patients with histologic improvement, endoscopic remission, endoscopic normalization, histologic-endoscopic mucosal improvement (HEMI), histologic-endoscopic mucosal remission (HEMR), and alternate HEMR (histologic remission and endoscopic normalization) at W104. P-values were calculated using Pearson chi-square test. Missing response data were imputed as non-response. Results: Among the Week 52 miri responders (N=239), 60.3% were male, with mean age of 43.9. Mean baseline modified Mayo Score was 6.7, and 33.5% had prior biologic or tofacitinib exposure. After 2 years of miri treatment, 65.3% patients achieved endoscopic remission and 51.9% achieved histologic remission. HEMI and HEMR were achieved by 53.1% and 47.7% of patients, respectively. A similar proportion of patients achieved histologic improvement, histologic remission, endoscopic remission, HEMI, and HEMR irrespective of prior biologic or tofacitinib failure, with only endoscopic normalization and alternate HEMR showing statistically significant higher rates for patients who didn´t have prior biologic or tofacitinib failure (Table 1). Conclusion: In LUCENT-3, sustained histologic and endoscopic remission were observed in patients with moderately-to-severely active UC who were treated with mirikizumab for 2 years, regardless of previous biologic or tofacitinib failure. Table 1. - Proportion of Patients with Histologic and Endoscopic Outcome at Week 104 by Prior Biologic or Tofacitinib Treatment Failure Status at Baseline Mirikizumab Response Rates at Week 104 Prior Biologic or Tofacitinib Not Failed (N=166) Prior Biologic or Tofacitinib Failed (N=73) Overall (N=239) Histologic improvement a 99 (59.6%) 43 (58.9%) 142 (59.4%) Histologic remission b 85 (51.2%) 39 (53.4%) 124 (51.9%) Endoscopic remission c 114 (68.7%) 42 (57.5%) 156 (65.3%) HEMI d 90 (54.2%) 37 (50.7%) 127 (53.1%) HEMR e 80 (48.2%) 34 (46.6%) 114 (47.7%) Endoscopic normalization f 56 (33.7%) 13 (17.8%) * 69 (28.9%) Alternate HEMR g 48 (28.9%) 11 (15.1%) * 59 (24.7%) Data presented as n (%); P-value, *P< 0.05. Abbreviations: ES = Endoscopic Subscore; HEMI = Histologic Endoscopic Mucosal Improvement; HEMR = Histologic Endoscopic Mucosal Remission.aGeboes score≤3.1.bGeboes score≤2B.0.cES=0 or 1, excluding friability.dGeboes score≤3.1 and ES=0 or 1, excluding friability.eGeboes score≤2B.0 and ES=0 or 1, excluding friability.fES=0.gES=0 and Geboes score≤2B.0.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".